Oral hygiene method and formula

ABSTRACT

The present invention generally relates to oral compositions such as toothpastes, toothpowders, liquid dentrifices, mouthwashes, rinses, dental floss, denture cleansers, chewing gums, lozenges and the like. In particular, it relates to such oral compositions that include cesium and rubidium salts. In one aspect of the present invention, a composition for oral use is provided. The composition includes a cesium or rubidium salt and water having a surface tension ranging between 45 and 70 dynes per cm 2 . In another aspect of the present invention, a method for improving oral hygiene in a mammal is provided. The method involves taking a volume of a solution into the mammal&#39;s mouth, where the solution includes a cesium or rubidium salt and water having a surface tension ranging between 45 and 70 dynes per cm 2 , swishing the solution around and expelling the solution.

This patent application is a continuation of U.S. patent applicationSer. No. 11/103,826, filed Apr. 12, 2005, which claims priority under 35U.S.C. 119 to U.S. Patent Application Ser. No. 60/561,784, filed on Apr.12, 2004. The referenced applications are herebyincorporated-by-reference in their entirety for all purposes.

FIELD OF THE INVENTION

The present invention generally relates to oral compositions such astoothpastes, toothpowders, liquid dentrifices, mouthwashes, rinses,denture cleansers, toothpicks, dental flosses, chewing gums, lozengesand the like. In particular, it relates to such oral compositions thatinclude cesium and rubidium salts.

BACKGROUND OF THE INVENTION

Therapies for treating oral disease are primarily directed to activeplaques, i.e., bacterial deposits on the surface of a tooth. Suchtherapies primarily rely on patient self-care, in the form of thoroughoral hygiene. The hygiene, which is only marginally effective, typicallyconsists of tooth brushing and interstitial hygiene using either dentalfloss or a toothpick.

Tooth cleaning by a dental professional removes plaque and cleans thedeep periodontal pockets inaccessible through self care. If professionalcleaning does not provide the desired, beneficial effect, the gums maybe folded aside during a surgical procedure, which enables furtheraccess to periodontal pockets. This approach often damages cell tissuesand promotes the viability of pathogens.

Chemotherapeutic agents may also be used to inhibit the formation ofdental plaque. Chlorhexidine, for example, is a cationic agent used forsuch purposes. It has substantial drawbacks, however, as it can causeteeth staining and has an unpleasant taste.

Dental hygiene and denture preparations typically contain anti-plaqueand/or anti-tartar agents, as well as antimicrobial agents Antimicrobialaction may only briefly affect the formation of plaque by eitherreducing the colony number of bacteria in the mouth/dentures or bykilling bacteria trapped in film. This procedure, however, does notreduce or eliminate the viability zone of oral pathogens to preventfurther growth.

There is accordingly a need for oral compositions and methods that haveprolonged, residual antimicrobial activity. The provision of suchcompositions and methods are objects of the present invention.

VARIOUS REFERENCES

M. W. Dodds et al., “The relationship between plaque pH, plaque acidanion profiles, and oral carbohydrate retention after ingestion ofseveral ‘reference foods’ by human subjects,” J. Dent Res, 67(5):861-5(May 1988)—Abstract Only.

S. Kalfas et al, Effect of pH on acid production from sorbitol in washedcell suspensions of oral bacteria, Caries Res, 24(2):107-12(1990)—Abstract Only.

M. W. Dodds et al., “Effects of dietary sucrose levels on pH fall andacid-anion profile in human dental plaque after a starch mouth-rinse,”Arch Oral Biol, 31(8):509-12 (1986)—Abstract only.

P. L. Schroeder et al., “Dental erosion and acid reflux disease,” AnnIntern Med, 122(11):809-15 (Jun. 1, 1995).

P. Lingstrom et al., “Effect of frequent consumption of starchy fooditems on enamel and dentin demineralization and on plaque pH in situ,” JDent Res, 73(3):652-60 (March 1994)—Abstract Only.

L. M. Macpherson et al., “An in vitro stimulation of the effects ofchewing sugar-free and sugar-containing chewing gums on pH changes indental plaque,” J Dent Res, 72(10):1391-7 (October 1993)—Abstract Only.

B. G. Bibby et al., “Oral food clearance and the pH of plaque andsaliva,” J Am Dent Assoc, 112(3):333-7 (March 1986)—Abstract Only.

D. C. Abelson et al., “The effect of saliva on plaque pH in vivo,” JDent Res, 60(9):1634-8 (September 1981)—Abstract Only.

A. Millward et al., “Continuous monitoring of salivary flow rate and pHat the surface of the dentition following consumption of acidicbeverages,” Caries Res, 31(1):44-9 (1997)—Abstract only.

G. L. Hays et al., “Salivary pH while dissolving vitamin C-containingtablets,” Am J Dent, 5(5):269-71 (October 1992)—Abstract Only.

K. Nilner et al., “Effect of a buffering sugar-free lozenge on intraoralpH and electrochemical action,” Acta Odontol Scand, 49(5):267-72(October 1991)—Abstract Only.

F. M. Eggert et al., “The pH of gingival crevices and periodontalpockets in children, teenagers and adults,” Arch Oral Biol, 36(3):233-8(1991)—Abstract Only.

G. Maglis et al., “Determination of saliva pH in periodontal diseasepatients and a control group,” Rev Dent Chile, 80(2):70-2 (August1989)—Abstract Only.

C. M. Christensen et al., “Salivary changes in solution pH: a source ofindividual differences in sour taste perception,” Physiol Behav,40(2):221-7 (1987)—Abstract Only.

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Lyda Associates Inc.® 1990, “Dental erosion by fruit,” NutritionResearch Newsletter, 9(1):6(2) (January 1990)—Abstract Only.

J. R. Newland, “Oral ulcers: keys to differential and definitivediagnosis,” Consultant, 29(5):157(11) (May 1989).

P. J. Moynihan et al., “A comparison of the relative acidogenicpotential of infant milk and soy infant formula: a plaque pH study,” IntJ Paediatr Dent, 6(3):177-81 (September 1996)—Abstract Only.

Jamie Talan, Newsday Newspaper Article entitled “Scientists gettingnearer to knocking out cavities without using fluoride,” p. D4 (January1997).

Lyda Associates Inc.® 1990, “Dental properties of soft drinks,”Nutrition Research Newsletter, 9(1:7(1) (January 1990).

C. C. Schurer-Maly et al., “Smoking and pH response to H2-receptorantagonists,” Scand J Gastroenterol, 24(10):1172-8 (December1989)—Abstract Only.

L. A. Elson et al., “The Sugar Content And The pH Of The Smoke OfCigarette, Cigar And Pipe Tobaccos In Relation To Lung Cancer,” Int JCancer, 9(3):666-675 (1972)—Abstract Only.

D. Birkhed et al., “pH Changes in Human Dental Plaque from Lactose andMilk before and After Adaptation,” Caries Res 27:43-50 (1993)—AbstractOnly.

C. J. Thomas et al., “Astringent subqualities in acids,” Chem Senses,20(6):593-600 (December 1995)—Abstract Only.

E. Bashir et al., Department of Cardiology, School of Dentistry,Karolinska Institutet, Huddinge, Sweden, “Site specificity of citricacid retention after an oral rinse,” Caries Res, 29(6):467-9(1995)—Abstract Only.

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News Bites, Single Sheet, “Sports Drinks: Bad for Teeth?” HealthNews, p.8 (Apr. 15, 1997).

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T. H. Grenby, “Comparison of the Cariostatic Effects of Calcium andSodium Glycerophosphates in Rats,” Hely. Odont. Acta, 17:54, 55 (October1973).

A. H. Brook et al., “A Clinical Study of the Effect of CalciumGlycerophosphate,” Helv. Odont. Acta, 17:55 (October 1973).

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Akademiia Nauk SSSR, Dobladay, 161(1):244-247 (1965). P. Vahl et al.,“Examination of the pH of saliva in children and juveniles in relationto caries, gingivitis and oral hygiene,” Stomatol DDR, 39(4):253-8(April 1989).

SUMMARY OF THE INVENTION

The present invention generally relates to oral compositions such astoothpastes, toothpowders, liquid dentrifices, mouthwashes, rinses,denture cleansers, toothpicks, dental flosses, chewing gums, lozengesand the like. In particular, it relates to such oral compositions thatinclude cesium and rubidium salts.

In one aspect of the present invention, a composition for oral use isprovided. The composition includes at least one cesium or rubidium saltand water having a surface tension ranging from 45 to 70 dynes per cm².

In another aspect of the present invention, a method for improving oralhygiene in a mammal is provided. The method involves taking a volume ofa solution into the mammal's mouth, where the solution includes a cesiumor rubidium salt and water having a surface tension ranging from 45 to70 dynes per cm², swishing the solution around and either swallowing orexpelling the solution.

In another aspect of the present invention, a paste for improving oralhygiene is provided. The paste includes a cesium or rubidium salt and anabrasive.

In another aspect of the present invention, a denture cleansingcomposition is provided. The denture cleansing composition includes acesium or rubidium salt and an effervescence generator.

In another aspect of the present invention, a method of controlling oralfluids is provided. The method involves applying a hemostatic dentalcomposition to an area within a mammal's mouth and subsequently applyinga second composition. The second composition includes a cesium orrubidium salt and water having a surface tension ranging from 45 to 70dynes per cm².

In another aspect of the present invention, a method for reducinginflammation within the mouth of a mammal is provided. The methodinvolves applying a composition comprising from about 500 ppm to about100,000 ppm, preferably about 1,000 ppm to about 10,000 ppm, of cesiumor rubidium ions to the inflamed area.

DETAILED DESCRIPTION OF THE INVENTION Definitions

Acidity and alkalinity are measured by pH, which is defined as thelogarithm of the Hydrogen ion activity: pH=−log (H+). The parameter pHeis the pH on the exterior and pHi is the pH on the interior of the cell.

Examples of acidic beverages, which are included within the term “acidicingestible” as used herein and which are commonly acidic, include beer,coffee including decaffeinated coffee, soft drinks including cola, fruitjuice, tomato juice, lemonade and wine, and at least partiallydehydrated versions generally with a pH below 3,3, or more specifically3.1.

Examples of acidic foods, which are included within the term “acidicingestible” as used herein, include tomato sauce and foods containingtomato sauce, such as spaghetti and pizza, pickles, citrus-flavoredwater ices and sherbets, salsa, pickled foods, and the like, generally,with a pH below 3.3 or more specifically 3.1.

As used herein, “acidic ingestible” also includes acidic medicaments.Such acidic medicaments include acid-based medicines or oral medicationsor dietary supplements having acidic active ingredients, excipients,vehicles or formulation ingredients. Such medicaments include, forexample, analgesics or anti-inflammatories and vitamins, such asaspirin, ibuprofen and vitamin C (ascorbic acid).

An acid is a substance consisting of molecules of ions which donateprotons (H+), and a base is a substance which accepts protons.

An acid-forming reaction is produced by any chemical reaction thatproduces a decreased ability to energize the biological system andleaves an acid residue, such as a hydrogen ion (H+). The result islocalized acidosis with induced hypoxia, a major cause of a wide varietyof degenerative oral diseases.

Plaque is initiated when bacteria adhered to pellicle form aproteinaceous film on the surface of teeth. The adherent bacteriametabolize dietary constituents and reproduce and aggregate to form thetenacious deposit known as plaque. Plaque generally consists ofbacteria, bacterial end products such as polysaccharides, inorganicsalts and salivary proteins. Plaque bacteria ferment dietarycarbohydrates to organic acids further reducing the pH whichdematerialize enamel resulting in tooth decay and contributed to a widevariety of acidotic, degenerative oral diseases.

Calculus is essentially plaque that has been mineralized with calciumphosphates salts. As calculus matures and hardens, it produces a staindue to adsorption of dietary chromagens. In addition to theirundesirable appearance, calculus deposits at the gum line are a majorcontributing factor to gingivitis and periodontal diseases. Besides thehygienic and health problems resulting from plaque, the primary sourceof halitosis (bad breath) is the retention and subsequent degradation ofdead cellular material sloughed off continuously by the normal, healthymouth.

The term “reducing acidity” or “to reduce the acidity of” as used hereinin relation to the mouth or the throat of a mammal means to raise and/ormaintain the pH of a surface or a portion of the mouth or the throat orthe saliva therein to or at a pH of about 6.0 or higher for up to aboutfive hours after ingestion of an acidic substance (i.e., leading to thedevelopment of dental cavities). The surface or portion of the mouth orthe throat or the saliva therein may include, by way of example and notby way of limitation, the surface or a portion of the teeth, the gums,and the back of the throat of a mammal.

When a mammal is a human, a human of any age, except an infant, isincluded.

Free radical: A free radical is an atom or molecule with an unpairedelectron, that is, the electron is not paired with another electron inthe formation of a chemical bond. Generally, this results in a moleculewith a net magnetic moment, so it is paramagnetic. Free radicals tend tobe unstable and they can damage other chemicals, tissues including DNAand RNA, etc.

The term “oral hygiene composition” as used herein includes, but is notlimited to, dentifrices, mouthwashes, toothpowders, chewing gums,lozenges and denture cleansing formulations.

The term “ionic active agent” as used herein donates an ionic agenthaving anticalculus and/or antistaining properties in accordance withthe invention, this undesirable staining is substantially reduced.

Introduction

Oral health can be influenced by many factors. One of the mostfundamental factors is the correct function of homeostatic regulation ofionic concentrations, pH and membrane electrical potentials. It iscurrently known that the biochemical activities of living cells arecontrolled by pH and ion concentrations, and many key processes, such asenergy metabolism and nerve and brain function, depend on membraneelectrical potential. It is also known that ion movements, correct pHand membrane electrical potential are closely linked through the actionof ion specific gates, electrogenic carriers and other ion carriers incell and organelle membranes.

Most oral degenerative diseases, including pathogen invasion andpropagation, are caused by a reduction in the pH, pHe and pHi andprogress though a complex series of pathological and electro-biologicalchanges from initial onset to full manifestation. Unfortunately, theprior art's drugs do not currently address the complexity of diseaseprocesses and the underlying causes or the mechanisms. This oftentimesmakes them difficult to understand without knowing the fundamentalelectro-biological and electro physical mechanisms.

There are many drugs and therapies aimed at correcting specific diseasesymptoms that result from failure to maintain the ideal ionicphysiological conditions. Preventative protection of the body fromfailure of homeostasis has generally been relegated largely to the realmof nutritional and lifestyle choices. The knowledge and understanding ofionic physiology enables us to provide oral formulations and methodsthat will make the protection of ionic homeostasis, such as minimizingthe accumulation of damage within the cells, etc., accessible andconvenient, resulting in profound benefits to human health.

The aberrant regulation of cellular homeostasis is a significant factorin the pathogenesis of disease onset. Raising the pH of the oral region,cellular pHe and cellular pHi reduces the excessive excitement ofneurons, processes the stressful biological inflammatory complex freeradical oxidative stress (such as super oxides, peroxides, oxyacids,alcohols and aldehydes), normalizes and stabilizes the ionichomeostasis, processes enzyme toxins and releases the useful molecularoxygen from its bound state. As an example, the central disorders ofacute maladaptive reactions are oxygen deficit and acidity. Thebiochemistry of chronic and acute degenerative diseases reveals the samedisorders as acute maladaptive reactions with a sub optimal pH thatproduces an acidic biological environment.

The biological environment of pathogens, anaerobic cells, has a narrowand specific viability zone and ORP range (hydrogen ion) limited to anarrow pH range, ranging between a pH of 5.5 to 7.1, with mostinfectious microorganisms ranging between 6.6 to 6.8. Healthy human oralcells, however, can exist in pH's and ORP's outside of a pathogen'sviability zone. By increasing negative hydrogen ions in the circulatingfluids and cells, the electrons tend to move those fluids increasing thepH toward an ORP and pH, in a range consistent with optimum physiologicaerobic metabolic functions. The optimum metabolic function and systemicpH promotes cellular function and repair through optimumelectro-biological environment conductivity and oral pH ranges of 7.21to 7.55, preferably 7.40.

Without the available electron donor's energy to reduce or eliminate theexcess H+ migration into viable healthy cells and tissues, the pH of theelectro-physical environment is reduced and compromised. This increasesbactericidal capacity that occurs at a reduced pH and concomitantlyreduces cell function; reduced pH unbalances signaling, further mountingan inflammatory response. This results in the onset and progression oforal disease. Therefore, altering or manipulating the oral region's pH,cellular pHe and pHi to an optimal or near optimal electro-physicalenvironment provides disease resistance.

Cesium and/or Rubidium ions provide an “electron bath.” Free radicalsare bathed in electrons, and they are then stabilized and no longer ableto induce cellular and tissue damage. The optimally functioningelectro-biological oral environment has a narrow pHe range from a lowpHe of 7.31 to 7.50, preferably between 7.37 and 7.42. The method andformula for oral pH increase and obtaining a reduction of the H+migration, providing resistance to oral diseases and disease invasion,produces ionic changes in the pH, pHe, pHi, and changes the ionicchemistry of the oral cells and tissues.

The present invention discloses a method and formula that shifts theoral pH and electrophysiological environment from one that promotes awide variety of oral diseases to a pH range that potentiates the optimumimmune function. Increasing the pH promotes the elimination of thepathogen's electrophysiological environment and promotes regeneration oforal cells and tissues by inducing optimum electro-physical cellularfunction, reversing molecular pathology and restoring cellularelectrochemical equilibrium. Secondarily, by stabilizing or reducing theoral acidosis and increasing oxygenation in the electro-biologicalenvironment, the hostile effects caused by acidosis (reduced pH) arereduced and eliminated, and optimum pH ranges are restored.

The formula and method will eliminate the oral acidification so that thephysiologic optimum pH approaches optimal, or near optimal ranges,between 7.21 to 7.55, preferably 7.37 to 7.41. If pHe is close tooptimum physiologic levels, metabolic function is not compromised andoral cellular regeneration and repair takes place.

Formulas and therapy, which enhance the ability of normal healthytissues and cells to correctly regulate pH and other elements ofcellular electrochemistry, and thereby reduce cell degeneration, damageand disease invasion will clearly be beneficial. Increasing cellularfunction will, at a minimum, delay the onset and ameliorate the effectof oral diseases (e.g., gingivitis progression to advancedperiodontitis).

Cesium and rubidium are the two most alkali metals with chemical andphysical characteristics similar to potassium. Potassium is the maininternal caution of living cells. Potassium ion currents are central tothe ionic physiology of normal viable healthy cells. Trans- membranefluxes and cellular accumulation of cesium and rubidium ions aregoverned by the similar cellular mechanisms as those which governpotassium movements; however, cesium and rubidium ions move at slowerrates and accumulate to different degrees. Cesium and rubidium ions areeffective for the control of potassium fluxes and linked hydrogen ionsand other ionic fluxes making them essential ionic elements for oraldisease resistance (prophylaxis)

Objects and Advantages of the Invention

An advantage of the invention is that it prevents and reduces theformation of an oral, acidic hypoxic biochemical environment, thusameliorating the effects of oral diseases, minimizing the damage withinthe cells and tissues, and lowering lifelong oral health costs.

A further advantage of the present invention is that it can be costeffectively administered as a stand alone therapy or as an effectiveadjunct in conjunction with a wide variety of known therapies.

An advantage of the present invention is to provide a therapeuticformula over an extended period of time to suppress infectiousmicroorganisms—i.e., bacteria, viruses, and parasitic diseases—andreduce the effect of carcinogens to maintain optimum oral health.

A further object of the invention is to provide oral nutritionalintervention, which is a composition that reduces oxidative stress byeliminating and preventing the formation of an acidic environment; itfurther reduces the production of free radicals.

A further object of the invention is to promote and maintain an oral pHeabove 7.00, preferably ranging from a pH of 7.21 to 7.55 (briefly) fordisease resistance, remission and prophylaxis.

A further object of the invention is to provide a method of treating orpreventing gum disease or dental caries by oral application ofcompositions of the present invention.

A further object of the present invention is to provide an anti-plaquemouth rinse which includes antibacterial agents to promote the deliveryto and retention of these agents in the mouth and soft tissues in thedental region of the oral cavity, thereby enhancing the antibacterialactivity inhibiting the development of oral diseases and plaque.

A further object of the invention is to provide new oral hygienecompositions which substantially improve the oral, electrochemicalenvironment, that alleviate the inflammatoric process and progressionfrom gingivitis to periodontitis, and also restablilize teeth in theirrespective sockets.

A further object of the invention is to provide oral hygienecompositions which reduce the formation of active plaques on the surfaceof the tooth to improve oral hygiene in mammals, including man.

A further object of the invention is to provide new compositions thatcontrol oral bleeding or provide gingival tissue fluid control inconjunction with hemostatic compositions.

A further object of the invention is to provide new compositions that,after application, improve bonding surfaces of teeth for the addition ofcaps and algums.

These objects are attained in an anti plaque mouth rinse conducive tooral hygiene. The mouth rinse or gel composition includes an aqueousvehicle having dissolved therein antibacterial, alkaline ionic agentsthat penetrate teeth, tissues and gums to obtain their delivery.Retention of the agents on teeth and soft tissue in the dental region ofthe oral cavity of the user is further promoted, thereby inhibiting theformation of plaque.

The present invention provides an alkaline, ionic, pH manipulatingformula and therapy for inhibiting acidotic activity (reduced pH) forrestoration and prophylaxis of a wide variety of oral diseases. Thetherapy involves the administration of sufficient quantities of alkalinesalts, in a suitable carrier, or in a wide variety of delivery formsthat provide for suitable ionic, pH, electrochemical andelectro-physiological requirements. More specifically, the treatment ofmammals, and more specifically human patients, involves theadministration of a therapeutically effective dose of a salt or salts ofcesium and/or rubidium with supportive electrolytes, vitamins, traceminerals and other nutrients.

If a dental patient's immune system is suppressed by an acidic oralbiological environment (localized reduced pH), either viral orbacterial-induced or age-related, the oral therapy described hereinprovides for an increase of the oral pH, cellular pHe and pHi to optimumranges during the therapy cycle. This accordingly stimulates thepatient's immune response and function to resist a wide variety of oralinfections and diseases, and to obtain prophylaxis thereof. It is knownto be effective to reduce levels of plaque that occurs in a reduced pHin the oral region of the mouth.

The invention discloses a mouthwash composition exhibiting plaquecontrol/reduced staining tendencies comprising a salt or salts,preferably cesium and/or rubidium salt or salts, and having a pH of from7.00 to 9.70, preferably 8.50 to 9.20.

According to the invention there is provided an oral hygiene compositioncomprising an effective amount of a water soluble ionic antimicrobialagent or an orally acceptable salt thereof, an effective amount of asubstantially water soluble ionic active agent or agents or an orallypharmaceutically acceptable salt thereof, thus ensuring effective oralantimicrobial action and allowing the composition to be stored for longperiods of time without deterioration. In one embodiment, the presentinvention provides an oral hygiene composition including anantimicrobial amount of an alkaline salt or salts containing ions ofcesium and/or rubidium or a orally acceptable salt/salts thereof and ananti staining ionic active agent.

The oral composition provides for antimicrobial activity whenadministered. This activity reduces or eliminates the acidoticenvironment that promotes tooth decay. As a result, dental caries isimproved and there is also simultaneous prophylaxis activity againstadditional tooth decay.

The oral composition may be formulated for use in any form ofinterdental or periodontal treatment and may be in the form of, forexample, a dentifrice, mouthwash, tooth cream toothpowder, dental floss,toothpaste, chewing gum, lozenge, mouth spray or impregnated toothpicks,floss etc. Such compositions may contain conventional materials if theydo not interfere with the alkaline ions mobility, such as, for example,humectants, gelling agents, abrasives, fluoride sources, desensitizingagents, flavorings, colorings, sweeteners, preservatives and structuringagents, and may also contain additional surfactants, anti-calculusagents and anti-plaque agents. Suitable additional surfactants arewater-soluble organic compounds, and may be nonionic, cationic oramphoteric species throughout a suitable pH range.

Structuring agents may be used in, for example, dentifrices and gums toprovide desirable textural properties and “mouth feel”. Suitable agentsinclude natural gum binders such as gum tragacanth, xanthan gum, gumkaraya and gum arabic, seaweed derivatives, smectite clays such asdiatomaceous earths, bentonite or hectorite, calcium apatite,carboxyvinyl polymers and water-soluble cellulose derivatives such ashydroxyethyl cellulose and sodium carboxymethyl cellulose. Improvedtexture may also be achieved, for example, by including colloidalmagnesium and or aluminum silicate. Suitably, the structuring agent isincluded in an amount of from 0-5%, preferably 0-3% by weight of theoral hygiene composition.

Suitable abrasives include silica abrasives, such as hydrated silicasand silica gels, particularly silica xerogels. Alternative abrasivesinclude alumina, insoluble metaphosphates such as insoluble sodiummetaphosphate, calcium carbonate, dicalcium phosphate (in dihydrate andanhydrous forms), and calcium pyrophosphate (including beta-phasecalcium). Calcium carbonate is a preferred abrasive. Abrasives aretypically included in an amount of from 0-80%, preferably 0-60%, morepreferably 5-25% by weight of the oral hygiene composition. Theabrasives typically have an average particle size of about 0.1-30microns, preferably about 5 to 15 microns.

Preferably, the oral compositions of the present invention include acesium or rubidium ion source present in an amount sufficient to providefrom about 500 ppm to about 100,000 ppm, preferably about 1,000 ppm toabout 10,000 ppm, cesium and/or rubidium. The inclusion of rubidiumand/or cesium salts is beneficial, as the corresponding cesium orrubidium ions will become incorporated into the hydroxyapatite of toothenamel, which increases resistance of the enamel to tooth decay.Inclusion of a cesium ion source is also desirable when a polyphosphate,anti-calculus agent is included in the composition. This will providefor the inhibition of polyphosphate enzymatic hydrolysis by salivaryphosphatase enzymes.

Flavoring agents may be included in the oral composition if desired, aslong as they do not substantially interfere with the ionic mobility ofcesium and/or rubidium. Such agents—e.g., oils of peppermint,wintergreen, sassafras and clove-are typically included to increase thepalatability of a composition. Sweeting agents such as the following mayalso be included: D-tryptophan, dextrose, levulose, acesulfam,dihydrochalcones and sodium cyclamate. Such flavoring or sweeteningagents are typically included in the oral hygiene composition in anamount from 0-5% by weight, preferably 0-2% by weight. Furthermore,coloring agents (e.g., colorants or pigments) may be added to improvethe visual appearance of the composition. Suitable colorants include,without limitation, dyes such as FD & C blue No. 1, D & C yellow No. 10and D & C yellow No. 3. A suitable and commonly used pigment is titaniumdioxide, which provides a white color.

Flavoring agents may be lipophilic or hydrophilic. Lipophilic flavorantsinclude, without limitation, wintergreen oil, oregano oil, bay leaf oil,peppermint oil, spearmint oil, clove oil, sage oil, sassafras oil, lemonoil, orange oil, anise oil, benzaldehyde, bitter almond oil, camphor,cedar leaf oil, marjoram oil, citronella oil, lavender oil, mustard oil,pine oil, pine needle oil, rosemary oil, thyme oil, cinnamon leaf oil,and mixtures thereof. Where used, lipophilic flavorants are typicallyincluded in the oral composition at a level from about 0.01%-10% byweight, preferably from about 0.05%-5.0% by weight, and more preferablyfrom about 0.1%-3.0% by weight.

Anti-calculus agents suitable for use in compositions of the presentinvention are cesium and/or rubidium salts. A preferred agent is cesiumcarbonate. Cesium and/or rubidium compounds can be present in amountssufficient to provide from about 500 ppm to about 100,000 ppm,preferably about 1,000 ppm to about 10,000 ppm of cesium and/or rubidiumions.

Other optional components for use in the present compositions include:antioxidants; vitamins (e.g., vitamin C and E); other anti-plaque agents(e.g., stannous salts, copper salts, and magnesium salts); pH adjustingagents; anticaries agents (e.g., urea, calcium glycerophosphate, andsodium trimetaphosphate), plant extracts; desensitizing agents forsensitive teeth (e.g., cesium nitrate and cesium citrate); and mixturesthereof.

Where the composition of the present invention is used as a mouth rinse,it is preferred that the ingredients of the aqueous solution areselected such that the composition may be ingestible, even by children.For example, the aqueous solution should be free of alcohol or otheractive ingredients which warrant poison control labeling or hazardlabeling indicating that the composition is to be kept away fromchildren. In a preferred mouth rinse embodiment, the ingredients of therinse composition do not include alcohol, cetylpyridinium chloride orwitch hazel (12-15% ethanol).

Where the composition of the present invention is used as a denturecleanser, it may additionally include one or more bleaching agents,effervescence generators, and chelating agents. The bleaching agent istypically an inorganic persalt. Examples bleaching agents include,without limitation, the following: alkali metal and ammoniumpersulphates, perborates percarbonates, perphosphates, and the alkalimetal ions and alkaline earth metal peroxides (including potassium,ammonium, sodium and cesium persulphates and perborate mono- andtetrahydrates, sodium pyrophosphate peroxyhydrate and magnesium,calcium, and zinc peroxides and mixtures thereof).

The denture cleansing compositions can also incorporate an effervescencegenerator, i.e. a material which in the presence of water releasescarbon dioxide or oxygen with effervescence. The effervescence generatorcan be selected from generators which are effective under acid, neutralor alkaline pH conditions, consisting of a combination of a generatorwhich is effective or most effective under acid or neutral pH conditionsand a generator which is effective or most effective under alkaline pHconditions. Effervescence generators that are effective under acid orneutral pH conditions include a combination of at least one alkali metalcarbonate or bicarbonate, such as sodium bicarbonate, sodium carbonate,sodium sesquicarbonate, potassium carbonate, potassium bicarbonate,germanium sesquaoxide or mixtures thereof, in admixture with at leastone non-toxic, physiologically-acceptable organic acid, such as but notlimited to tartaric, fumaric, citric, malic, maleic, gluconic, succinic,salicylic, adipic or sulphamic acid, sodium fumarate, sodium orpotassium acid phosphates.

In denture cleansing compositions in tablet form, the effervescencegenerator takes the form of a solid base material which in the presenceof water releases carbon dioxide or oxygen with effervescence. Suitably,the solid base material incorporates a (bi) carbonate/acid effervescentcouple optionally in combination with a perborate/persulphate oxygeneffervescence generator. The combination of generators is valuable forachieving optimum dissolution characteristics and pH conditions forachieving optimum cleaning and antimicrobial activity. The (bi)carbonate components generally comprise from about 5% to about 65%,preferably from about 25% to 55% of the total composition; the acidcomponents generally comprise from about 5% to about 50%, preferablyfrom about 10% to about 30% of the total composition.

Preferred from the viewpoint of optimum dissolution and pHcharacteristics are bleach precursor agglomerates which comprise fromabout 10% to about 75%, preferably from about 20% to about 60% by weightthereof of peroxyacid bleach precursor, from about 5% to about 60%preferably from about 5% to about 50%, more preferably from about 10% toabout 40% of a (bi)carbonate/acid effervescent couple, from about 0% toabout 20% of a peroxoborate, and from about 5% to about 40%, preferablyfrom about 10% to about 30% of an agglomerating agent. The final bleachprecursor granules desirably have an average particle size of from about500 to about 1500, preferably from about 500 to about 1,000μ, this beingvaluable from the viewpoint of optimum dissolution performance andassociated aesthetics. The level of bleach precursor agglomerates,moreover, is preferably from about 1% to about 20%, more preferably fromabout 5% to about 15% by weight of composition.

The denture cleansing compositions of the invention can be in paste,tablet, granular or powder form, although tablet-form compositions arepreferred herein. Compositions in tablet form can be single or multiplelayered tablets.

Denture cleansing compositions of the invention can be supplemented bycomponents such as surfactants, chelating agents, enzymes, flavorants,physiological cooling agents, antimicrobial compounds, dyestuffs,sweeteners, tablet binders and fillers, foam depressants (e.g.,dimethylpolysiloxanes), foam stabilizers (e.g., fatty acid sugaresters), preservatives, lubricants (e.g., talc), magnesium stearate,finely divided amorphous pyrogenic silicas, etc. The free moisturecontent of the final composition is desirably less than about 1% andespecially less than about 0.5%.

Chelating agents beneficially aid cleaning and bleach stability bykeeping metal ions, such as calcium, potassium, magnesium, and heavymetal cations, in solution. Examples of suitable chelating agents mayinclude sodium tripolyphosphate, calcium EDTA, germanium sesquaoxide,sodium acid pyrophosphate, tetrasodium pyrophosphate,aminopolycarboxylates (e.g., nitrilotriacetic acid and ethylenediaminetetracetic acid and salts thereof), and polyphosphonates andaminopolyphosphonates (e.g., hydroxyethanediphosphonic acid and saltsthereof).

The chelating agent selected must be compatible with the active ionicingredients of the denture cleanser when in the dry state and in aqueoussolution. Advantageously, the chelating agent comprises between 0.1 and60 percent by weight of the composition and preferably between 0.5 and30 percent. Phosphonic acid chelating agents, however, preferablycomprise from about 0.1 to about 1 percent, preferably from about 0.1%to about 0.5% by weight of composition.

Compositions of the present invention may also be used in conjunctionwith hemostatic dental compositions. The compositions are typicallyapplied after the hemostatic compositions in the form of a liquid, apaste, a gel, an impregnated fabric strip (e.g., bandage) or animpregnated surgical sponge. The compositions preferably include eithera cesium or a rubidium salt, preferably cesium chloride, cesium malate,cesium sulfate, and cesium nitrate.

Hemostatic compositions used with compositions of the present inventionmay include agents such as aluminum chloride, aluminum ammonium sulfate,ferric sulfate, oxidized regenerated cellulose (e.g., Surgicel™. fromJohnson and Johnson), and absorbably gelatin (e.g., GELFOAM®. fromUpJohn). Preferred hemostatic agents are aluminum chloride and aluminumammonium sulfate.

The combination of hemostatic dental compositions and compositions ofthe present invention stop oral bleeding and provide gingival tissuefluid control without opening up the dentinal tubules in dentin.Furthermore, by using the subject compositions during dental restorativeand reconstructive procedures, bleeding can be stopped so that anaccurate impression for a dental prosthetic can be made. Theconformational tolerance of the impression mold is significantlyincreased.

Any combination of cesium and/or rubidium salts which disassociate andionize may be employed in the composition of the present invention,including,but not limited to: Arginate, Ascorbate, Caprylate, Chloride,Cysteinate, Citrate, Fumarate, Humic, Fulvate, Methionine, Glutamate,Gluconate, Glycinate, Aspartate, Lysinate, Succinate, Carbonate,Lactate, Malate, Tartrate, Chloride, Sulfate, Phosphate, Nitrate,Fluoride, Bromide, Iodide, Orotate.

Additionally, other cesium and rubidium salts might be used in a widevariety of compositions, such as, but not limited to, various organic ormetallic salts, if they meet the following requirements: (1) they mustbe pharmaceutically acceptable and have an acceptably low level oftoxicity; (2) they must have sufficiently high levels of cationic(alkaline) dissociation to allow the remaining negatively charged ionsto effectively reduce the oral cavity acidity, including tissues.

The salts included in the composition of the present invention may beformed using a wide variety of acids, including, but not limited to:hydrochloric, humic, fulvic, sulfuric, acetic, lactic, tartaric, malic,succinic, etc. Ortho acids are preferred; more preferably, malic acidand citric acid are preferred acids.

Potentiation of cesium and/or rubidium ionic action can be accomplishedby inclusion of ingredients that enhance ionic pH physiology. Examplesare electrolytes (saline compounds) such as potassium, sodium, andmagnesium. Potassium, and other major electrolytes (e.g., sodium,calcium, chloride, bicarbonate, phosphate, and sulfates) are added tothe formulation in proportion to the potassium.

Other ingredients that may be included to potentiate the activity ofcesium/rubidium ionic action include manganese, zinc, boron, vitamin B2,B12 (cyanocbalamin), and B6 (pyrodoxine).

The water used in the manufacture of end-product compositions of thepresent invention may be from any suitable source. A preferred method ofmanufacture is to use water processed by means such as E.C.A.(electrolytic chemical activation) processing. The method producesaqueous solutions having certain characteristics. For example, anaqueous solution (water) for an oral rinse may be processed having asurface tension ranging between 45 to 70 dynes per cm² producing an ORP(oxidative reduction potential) ranging between −5 m.v. to −250 m.v.,preferably ranging between −10 m.v. to −125 m.v. The pH for suchcompositions ranges between 6.50 to 8.50, preferably 6.90 to 8.40.

The oral compositions of the present invention may be administered byany acceptable route. One typical route is the topical application asrinse, gel or paste. A further route is through application of asurgical bandage, where the composition is impregnated within thebandage.

Examples of formulations/forms for compositions of the present inventioninclude, without limitation, the following: gels, oils,bandages/dressings, topical lotions, solutions, or drop dispersions,encapsulation in liposomes, micro-particles, enteric coatings,microcapsules, and transdermal patches.

Long-acting compositions may be administered, for example, every 8 hoursor every day. Juvenile doses are generally about ½ of the adult range,depending on a variety of factors including weight and route ofdelivery.

The optimally effective formula and dosage(s) are adjusted (increased ordecreased) as therapy progresses. A patient's saliva pH should bemonitored during the treatment process and the dosage appropriatelyadjusted. The goal of dosage adjustment is to partially or whollyrestore and maintain the physiologic optimum oral pH range between 7.0to 7.55 and the corresponding cellular pHi above 6.40, preferablyranging between 6.41 to 6.80.

Cesium and rubidium ions used in the present are separate and distinctfrom man-made isotopes of cesium and rubidium.

EXAMPLES Example 1

A sixty year old male having active periodontal (stage II and localizedstage III) disease took a composition into his mouth, swished it aroundfor approximately 20 to 30 seconds and expelled it twice daily for aperiod of about 2 months. The composition included cesium chloride (30mg), rubidium chloride (10 mg), potassium citrate (350 mg) and magnesiumascorbate (20 mg) in 6 to 8 ounces of warm water. The treatment resultedin substantial suppression and elimination of the patient's periodontaldisease. Inflammation and bleeding within gingival tissues wereeliminated, and plaque deposits went from being moderate to very slight.

Example 2

An eighty-two year old female having ulcers on her tongue and gums thesize of a dime for over a year took a composition into her mouth,swished it around for approximately 20 to 30 seconds and expelled ittwice daily. The composition included CsCl (50 mg), potassium (110 mg),calcium (25 mg), magnesium (30 mg), manganese (0.5 mg) and chromium (5mcg) in 6 to 8 ounces of warm water. After 4 days, ulceration on hertongue and gums disappeared.

Example 3

A forty-seven year old male having swollen and bleeding gums and looseteeth took a composition into his mouth, swished it around forapproximately 20 to 30 seconds and expelled it twice daily. (The gumproblem had persisted for more than 20 years.) The composition includedcesium chloride (15 mg), rubidium chloride (5 mg), potassium citrate(175 mg) and magnesium ascorbate (10 mg) in 6 to 8 ounces of warm water.After 4 days, the patient could reinsert a dental bridge that had beenpreviously uninsertable; after 8 days, all gum swelling, gum bleedingand tooth looseness disappeared. (Testing saliva pH pretreatmentresulted in a reading of 5.9; it was between 7.1 and 7.2 seven days posttreatment.)

1. A composition for oral use, wherein the composition comprises: (a) acesium or rubidium salt; and, (b) water having a surface tension rangingbetween 50 and 70 dynes per cm². 2-28. (canceled)
 29. A method forimproving oral hygiene in a mammal, wherein the method comprises thefollowing steps: (a) taking a volume of a solution into the mammal'smouth, wherein the solution consists of a cesium salt, and wherein thecesium salt is selected from a group consisting of cesium arginate,cesium ascorbate, cesium caprylate, cesium cysteinate, cesium fumarate,cesium humate, cesium fulvate, cesium methionate, cesium glutamate,cesium gluconate, cesium glycinate, cesium aspartate, cesium lysinate,cesium succinate, cesium carbonate, cesium lactate, cesium malate,cesium tartrate, cesium chloride, cesium sulfate, cesium phosphonate,cesium nitrate, cesium bromide, cesium iodide, and cesium orotate ,water, one or more electrolytes at a pH ranging from 7.00 to 9.70; (b)swishing the solution around; and, (c) expelling the solution therebyimproving the mammal's oral hygiene.
 30. The method according to claim29, wherein the electrolyte is selected from a group of electrolytesconsisting of: sodium, potassium, bicarbonate, sulfate and phosphate.31. The method according to claim 29, wherein the solution furtherconsists of a flavorant.
 32. The method according to claim 29, whereinthe cesium salt is selected from a group consisting of: cesiumcarbonate; cesium lactate; cesium tartrate; cesium chloride; and cesiumsulfate.
 33. The method according to claim 30, wherein wherein thesolution further consists of a flavorant.
 34. The method according toclaim 33, wherein the cesium salt is selected from a group consistingof: cesium carbonate; cesium lactate; cesium tartrate; cesium chloride;and cesium sulfate.